New American College of Rheumatology criteria for fibromyalgia: a twenty-year journey.

*Abstract*

OBJECTIVE: To develop simple, practical criteria for clinical diagnosis of
fibromyalgia that are suitable for use in primary and specialty care and
that do not require a tender point examination, and to provide a severity
scale for characteristic fibromyalgia symptoms.

METHODS: We performed a multicenter study of 829 previously diagnosed
fibromyalgia patients and controls using physician physical and interview
examinations, including a widespread pain index (WPI), a measure of the
number of painful body regions. Random forest and recursive partitioning
analyses were used to guide the development of a case definition of
fibromyalgia, to develop criteria, and to construct a symptom severity (SS)
scale.

RESULTS: Approximately 25% of fibromyalgia patients did not satisfy the
American College of Rheumatology (ACR) 1990 classification criteria at the
time of the study. The most important diagnostic variables were WPI and
categorical scales for cognitive symptoms, unrefreshed sleep, fatigue, and
number of somatic symptoms. The categorical scales were summed to create an
SS scale. We combined the SS scale and the WPI to recommend a new case
definition of fibromyalgia: (WPI > or =7 AND SS > or =5) OR (WPI 3-6 AND SS
> or =9).

CONCLUSION: This simple clinical case definition of fibromyalgia correctly
classifies 88.1% of cases classified by the ACR classification criteria, and
does not require a physical or tender point examination. The SS scale
enables assessment of fibromyalgia symptom severity in persons with current
or previous fibromyalgia, and in those to whom the criteria have not been
applied. It will be especially useful in the longitudinal evaluation of
patients with marked symptom variability.

I wonder could this lead to a blurring of CFS and FMS. Leonard Jason found in the Chicago population study that only 16% of those with the Fukuda criteria had FMS (with clinic samples, the figures have tended to be higher). I think all the figures will be higher again with this definition but that's because they're using a lot of ME/CFS symptoms.

The American College of Rheumatology (ACR) is proposing a new set of diagnostic criteria for fibromyalgia that includes common symptoms such as fatigue, sleep disturbances, and cognitive problems, as well as pain. The new criteria are published in the May issue of the ACR journal Arthritis Care & Research.

"These new criteria recognize that fibromyalgia is more than just body pain," said Robert S. Katz, one of the authors of the new criteria and a rheumatologist at Rush University Medical Center.
"This is a big deal for patients who suffer symptoms but have had no diagnosis. A definite diagnosis can lead to more focused and successful treatment and reducing the stress of the unknown."

Routine lab tests can not detect fibromyalgia, a condition that is characterized by unexplained pain from head to toe and exhaustion. Instead, the diagnosis has been made by a tender point test, a physical exam that focuses on 18 points throughout the body. When light pressure is applied to these points, clustered around the neck, shoulder, chest, hip, knee, and elbow regions, patients with fibromyalgia feel tenderness or pain.

To meet the previous diagnostic criteria, which were established in 1990, patients must have widespread pain in all four quadrants of their body for a minimum duration of three months and experience moderate pain and tenderness at a minimum of 11 of the 18 specified tender points.

"There are numerous shortcomings with the previous criteria, which didn't take into account the importance of common symptoms including significant fatigue, a lack of mental clarity and forgetfulness, sleep problems and an impaired ability to function doing normal activities," said Katz.

According to Katz, fibromyalgia pain may fluctuate, which can affect the number of tender points, and the tender point test did not adequately measure symptom severity or the effectiveness of new treatments. "The tender point test also has a gender bias because men may report widespread pain, but they generally aren't as tender as women. Fibromyalgia may be under-diagnosed in both men and women because of the reliance on 11 tender points, and also due to failing to account for the other central features of the illness," said Katz.

Additionally, due to the confusion regarding the tender point test, the authors note that most primary care doctors don't bother to check tender points or they aren't checking them correctly.
Consequently, fibromyalgia diagnosis in practice has often been a symptom-based diagnosis. The new criteria will standardize a symptom- based diagnosis so that all doctors are using the same process.

The tender point test is being replaced with a widespread pain index and a symptom severity scale. The widespread pain index score is determined by counting the number of areas on the body where the patient has felt pain in the last week. The checklist includes 19 specified areas.

The symptom severity score is determined by rating on a scale of zero to three, three being the most pervasive, the severity of three common symptoms: fatigue, waking unrefreshed and cognitive symptoms.
An additional three points can be added to account for the extent of additional symptoms such as numbness, dizziness, nausea, irritable bowel syndrome or depression. The final score is between 0 and 12.

To meet the criteria for a diagnosis of fibromyalgia a patient would have seven or more pain areas and a symptom severity score of five or more; or three to six pain areas and a symptom severity score of nine or more.

Some criteria will remain unchanged. The symptoms must have been present for at least three months, and the patient does not have a disorder that would otherwise explain the pain.

To develop and test the new criteria, researchers performed a multicenter study of 829 previously diagnosed fibromyalgia patients and a control group of rheumatic patients with non-inflammatory disorders using physician physical and interview examinations. The data were processed by the National Data Bank for Rheumatic Diseases.

The authors note the study has a number of limitations. They recommend a follow-up test in the primary care setting that includes patients with other rheumatic conditions to determine the rate of misclassification that may occur.

###
The study was funded by Lilly Research Laboratories. Lilly Research Laboratories did not participate in the design of the study, see the results of the study, or review the manuscript or submitted abstracts.

Rush University Medical Center, located in Chicago, Illinois, is an academic medical center that encompasses the 676-bed hospital (including Rush Children's Hospital), the Johnston R. Bowman Health Center and Rush University. Rush University, with more than 1,730 students, is home to one of the first medical schools in the Midwest, and one of the nation's top-ranked nursing colleges. Rush University also offers graduate programs in allied health and the basic sciences. Rush is noted for bringing together clinical care and research to address major health problems, including arthritis and orthopedic disorders, cancer, heart disease, mental illness, neurological disorders and diseases associated with aging.

Classic ME had severe muscle pain as a core symptom. I suspect that the close association of CFS with FM is because CFS needs a separate diagnosis for the severe pain.

I thought it was only the trigger points that distinguished the two diseases.

It is important, because FM responds to gentle exercise but ME is made worse.

Mithriel

Click to expand...

The thing with the new definition is that it is to save the doctor from doing the trigger point evaluation. If one scores nine on the symptoms criteria, one only then needs to score pain in 3 of the 19 tender point regions by questionnaire and one qualifies.

The American College of Rheumatology is proposing to change their diagnostic criteria for fibromyalgia. Looks like there will be a big overlap with the case definitions for CFS. I've always viewed CFS and FM as distinct conditions, though certainly many people have satisfied the diagnostic criteria for both in the past. But there are PWCs who don't have pain, and PWFs who don't have fatigue, aren't there? This change seems to muddy the waters.

Best regards,

Rich

New Criteria Proposed For Diagnosing Fibromyalgia Suggests No Longer Focusing On Tender Points
26 May 2010

The American College of Rheumatology (ACR) is proposing a new set of diagnostic criteria for fibromyalgia that includes common symptoms such as fatigue, sleep disturbances, and cognitive problems, as well as pain. The new criteria are published in the May issue of the ACR journalArthritis Care & Research.

"These new criteria recognize that fibromyalgia is more than just body pain," said Robert S. Katz, one of the authors of the new criteria and a rheumatologist at Rush University Medical Center. "This is a big deal for patients who suffer symptoms but have had no diagnosis. A definite diagnosis can lead to more focused and successful treatment and reducing the stress of the unknown."

Routine lab tests can not detect fibromyalgia, a condition that is characterized by unexplained pain from head to toe and exhaustion. Instead, the diagnosis has been made by a tender point test, a physical exam that focuses on 18 points throughout the body. When light pressure is applied to these points, clustered around the neck, shoulder, chest, hip, knee, and elbow regions, patients with fibromyalgia feel tenderness or pain.

To meet the previous diagnostic criteria, which were established in 1990, patients must have widespread pain in all four quadrants of their body for a minimum duration of three months and experience moderate pain and tenderness at a minimum of 11 of the 18 specified tender points.

"There are numerous shortcomings with the previous criteria, which didn't take into account the importance of common symptoms including significant fatigue, a lack of mental clarity and forgetfulness, sleep problems and an impaired ability to function doing normal activities," said Katz.

According to Katz, fibromyalgia pain may fluctuate, which can affect the number of tender points, and the tender point test did not adequately measure symptom severity or the effectiveness of new treatments.

"The tender point test also has a gender bias because men may report widespread pain, but they generally aren't as tender as women. Fibromyalgia may be under-diagnosed in both men and women because of the reliance on 11 tender points, and also due to failing to account for the other central features of the illness," said Katz.

Additionally, due to the confusion regarding the tender point test, the authors note that most primary care doctors don't bother to check tender points or they aren't checking them correctly. Consequently, fibromyalgia diagnosis in practice has often been a symptom-based diagnosis. The new criteria will standardize a symptom-based diagnosis so that all doctors are using the same process.

The tender point test is being replaced with a widespread pain index and a symptom severity scale. The widespread pain index score is determined by counting the number of areas on the body where the patient has felt pain in the last week. The checklist includes 19 specified areas.

The symptom severity score is determined by rating on a scale of zero to three, three being the most pervasive, the severity of three common symptoms: fatigue, waking unrefreshed and cognitive symptoms. An additional three points can be added to account for the extent of additional symptoms such as numbness, dizziness, nausea, irritable bowel syndrome or depression. The final score is between 0 and 12.

To meet the criteria for a diagnosis of fibromyalgia a patient would have seven or more pain areas and a symptom severity score of five or more; or three to six pain areas and a symptom severity score of nine or more.

Some criteria will remain unchanged. The symptoms must have been present for at least three months, and the patient does not have a disorder that would otherwise explain the pain.

To develop and test the new criteria, researchers performed a multicenter study of 829 previously diagnosed fibromyalgia patients and a control group of rheumatic patients with non-inflammatory disorders using physician physical and interview examinations. The data were processed by the National Data Bank for Rheumatic Diseases.

The authors note the study has a number of limitations. They recommend a follow-up test in the primary care setting that includes patients with other rheumatic conditions to determine the rate of misclassification that may occur.

The study was funded by Lilly Research Laboratories. Lilly Research Laboratories did not participate in the design of the study, see the results of the study, or review the manuscript or submitted abstracts.

Rush University Medical Center, located in Chicago, Illinois, is an academic medical center that encompasses the 676-bed hospital (including Rush Children's Hospital), the Johnston R. Bowman Health Center and Rush University. Rush University, with more than 1,730 students, is home to one of the first medical schools in the Midwest, and one of the nation's top-ranked nursing colleges. Rush University also offers graduate programs in allied health and the basic sciences. Rush is noted for bringing together clinical care and research to address major health problems, including arthritis and orthopedic disorders, cancer, heart disease, mental illness, neurological disorders and diseases associated with aging.

I had read what was the "proposed" criteria fairly recently and I was appalled that the guy heading the preliminary effort (Frederick Wolfe, M.D.) makes two unflattering statements about fibromyalgia:

"The ACR diagnostic criteria should not be seen as an endorsement of the legitimacy and existence of fibromyalgia-the criteria are neutral on that point."3 He goes on to indicate that the "fibromyalgia wars" over whether fibro is a real condition, or just the end of the spectrum showing how some people poorly respond to distress (it's what Wolfe refers to as "fibromyalgianess"), remain unresolved.4

"... one can now study fibromyalgia and fibromyalgianess without the requirement for belief in its existence." Does this mean that Wolfe and other non-believers will enter the research field of fibromyalgia? Time will tell. With the new criteria that is virtually a symptom checklist, Wolfe adds, "... it is now possible to study widespread pain, fibromyalgia, fibromyalgianess-indeed the whole spectrum of illness related symptoms, simply and inexpensively in survey research." But this form of "study" is not likely to lead to biomarkers or effective new therapies, which is what fibromyalgia patients need the most.

They're doing the same thing with fibromyalgia that the Oxford criteria did with ME/CFS: water it down to ensure that you don't have a homogenous patient cohort, thereby rendering research meaningless, and making it almost impossible to identify a biomarker. This stuff makes me mad, because it is not good science and it's not respectful of the patients.

Fibromyalgianess??? I guess that's the equivilant of "unwellness" in ME/CFS.

"... one can now study fibromyalgia and fibromyalgianess without the requirement for belief in its existence."

Click to expand...

This leaves me virtually speechless. Friggin' amazing.

Now look at the list of jounals this guy is a reviewer/referee for:

American Family Physician
American Journal of Medicine
Annals of Internal Medicine
Annals of the Rheumatic Diseases
Arthritis and Rheumatism
Arthritis Care and Research
British Journal of Rheumatology
Clinical and Experimental Rheumatology
Clinical Rheumatology in practice
Clinical Rheumatology
Diabetic Medicine
Journal of Musculoskeletal Pain
Journal of Rheumatology
Journal of the American Medical Association
Journal of Clinical Epidemiology
Journal of Psychosomatic Research
New England Journal of Medicine
Pain
Osteoarthritis and Cartilage
Psychosomatic Medicine
Scandinavian Journal of Rheumatology
Seminars in Arthritis and Rheumatism
The Lancet
Western Journal of Medicine
Journal of Outcome Measurement

Myalgic encephalomyelitis has severe muscle pain as one of its symptoms - a doctor who was at the Royal Free told me that patients screamed if you touched them. That's why they called it myalgic.

CFS doesn't have the same emphasis on pain.

My pain was accounted for when I was diagnosed with ME, I didn't need an extra diagnosis of FM. It looks perfectly possible with this new set of criteria for patients with ME to be told they have FM. Yet if they are encouraged to do gentle exercise they could become severely and permanently disabled. (Too much walking put me into a wheelchair twenty years ago).

I think it is dangerous and I agree that it seems to be widening fibromyalgia to its detriment.

I had read what was the "proposed" criteria fairly recently and I was appalled that the guy heading the preliminary effort (Frederick Wolfe, M.D.) makes two unflattering statements about fibromyalgia:

"The ACR diagnostic criteria should not be seen as an endorsement of the legitimacy and existence of fibromyalgia-the criteria are neutral on that point."3 He goes on to indicate that the "fibromyalgia wars" over whether fibro is a real condition, or just the end of the spectrum showing how some people poorly respond to distress (it's what Wolfe refers to as "fibromyalgianess"), remain unresolved.4

"... one can now study fibromyalgia and fibromyalgianess without the requirement for belief in its existence." Does this mean that Wolfe and other non-believers will enter the research field of fibromyalgia? Time will tell. With the new criteria that is virtually a symptom checklist, Wolfe adds, "... it is now possible to study widespread pain, fibromyalgia, fibromyalgianess-indeed the whole spectrum of illness related symptoms, simply and inexpensively in survey research." But this form of "study" is not likely to lead to biomarkers or effective new therapies, which is what fibromyalgia patients need the most.

Not that it is any surprise to anyone on this forum but I find most docs in the mainstream of healthcare continue to be largely ignorant of FM and ME/CFS.

Click to expand...

Is Dr. Wolfe behind this new criteria or just chomping at the bit to use it to show Fibro doesn't exist? His unflattering opinions about Fibro go back a long time. His articles are still used by defense lawyers and ins. co's today.

"Dr. Frederick Wolfe, the chair of the American Rheumatological Committee, has stated that he no longer thinks of fibromyalgia as a disease, but only as a "clinical term" (Wolfe 1997, pp. 1247-49)."

"Fibromyalgia cannot occur as a result of trauma. The recommendation of the 1996 revision of the American Rheumatology Association excluded "reactive" and "posttraumatic fibromyalgia" as a cause of fibromyalgia (Wolfe 1996, p. 537). Based on the association's criteria, this would appear to exclude car accidents, falls and other traumatic incidents as acceptable causes of fibromyalgia."

"Therapies should not be continuous or indefinite. The goal of therapy is to make the patient independent."

"Dr. Frederick Wolfe makes a clear statement that "people with fibromyalgia should not be considered disabled" (Wolfe 1997).

"As a defense attorney, the following might be a good recommended checklist for fibromyalgia cases:

Contend that the applicant does not have fibromyalgia and may have something else.
Contend that fibromyalgia was not caused, aggravated or exacerbated by work. If work did "light up fibromyalgia," for how long? Causation is difficult to establish due to Dr. Wolfe's denouncing the criteria, the differences among professionals on the tender points checked, and the conflicts on what causes or aggravates fibromyalgia.
Contend hat if the applicant does have fibromyalgia, it was a pre-existing condition and request apportionment.
Look to see if histories and current activity levels are accurate."

The sensing of pain is a highly complex pathway with many components. It is inevitable that it will go wrong in some people. It is much more complicated than blood clotting, say, yet we know how many steps can malfunction in that.

But, like all complex medical problems, rather than admit to ignorance and do the research that will fill in the gaps in knowledge, the knee jerk reaction is to disbelieve it is happening at all, or to decide the patients are exaggerating, lying or mentally ill.